The impact of proactive versus reactive drug monitoring of infliximab on treatment outcomes in patients with crohn’s disease

Abstract

Background

Therapeutic drug monitoring (TDM) plays a crucial role in the management of Crohn’s disease (CD) patients receiving infliximab (IFX). While reactive TDM has been more commonly utilized previously, recent research suggests that proactive TDM may offer greater benefits for patients.

Objective

To compare treatment outcomes among patients receiving different monitoring modalities of IFX.

Methods

This was a retrospective cohort study that enrolled 142 CD patients who initiated IFX therapy at the First Affiliated Hospital of Nanjing Medical University from January 2014 to June 2021. The patients were divided into a reactive (n = 43) and proactive (n = 99) group. The outcome measures included sustained clinical response and remission rates, biological remission rates, endoscopic response and remission rates achieved in both groups at weeks 30 and 54. The incidence of adverse events (AEs), changes in IFX trough concentrations (TCs) and treatment adjustments within 54 weeks were also evaluated.

Results

Kaplan-Meier analysis demonstrated that the proactive group exhibited significantly higher cumulative probabilities of sustained clinical response, sustained clinical remission, and endoscopic response by Week 54. Compared to the reactive group, patients in the proactive group achieved significantly reduced rates of AEs-related hospitalization and surgery. After adjusting treatment strategies, the median concentration and the proportion of patients achieved an effective therapeutic concentration (TC > 3 μg/mL) at Week 54 was both significantly higher in the proactive group.

Conclusions

Proactive TDM of IFX plays a more crucial role in timely adjustment of treatment strategies and maintenance of effective concentrations, thereby contributing to the outcomes for CD patients.

Keywords:

• Crohn disease
• infliximab
• therapeutic drug monitoring
• anti-drug antibody

Author contributions

Yue Zhang was responsible for the study concept and design, acquisition of data, analysis and interpretation of data and drafting of the manuscript. Hongjie Zhang and Jie Chen were responsible for the review and confirmation of study design and results. Hongjie Zhang, Wenyu Jiang, Chenjing Xu, and Jiahui Tian were responsible for critical revision of the manuscript for important intellectual content. All authors approved the final version of the manuscript submitted and have agreed to be accountable for all aspects of the work.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This study was fully funded by the Natural Science Foundation of China, grant number: 82070568 and 81600416.